COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    NCT03616899
Previous Study | Return to List | Next Study

Safety and Efficacy of KPI-121 in Subjects With DED (STRIDE 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03616899
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : May 6, 2020
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Brief Summary:
The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Condition or disease Intervention/treatment Phase
Kerato Conjunctivitis Sicca Drug: KPI-121 Ophthalmic Suspension Drug: Vehicle Phase 3

Detailed Description:
This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 901 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : February 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Active Comparator: KPI-121 0.25% Ophthalmic Suspension Drug: KPI-121 Ophthalmic Suspension
KPI-121 Ophthalmic Suspension

Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspension Drug: Vehicle
Vehicle for KPI-121 0.25% ophthalmic suspension

Primary Outcome Measures :
  1. Ocular Discomfort [ Time Frame: 2 weeks ]
    Patient-reported ocular discomfort'

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion Criteria:

  • Known hypersensitivity or contraindication to the investigational product(s) or components
  • History of glaucoma, IOP>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
  • Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening.
  • In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03616899

Show Show 81 study locations
Sponsors and Collaborators
Kala Pharmaceuticals, Inc.
Layout table for additonal information
Responsible Party: Kala Pharmaceuticals, Inc. Identifier: NCT03616899    
Other Study ID Numbers: KPI-121-C-011
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases